BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3810775 · Received March 21, 2014

    Report

    Report Number
    2242352-2014-00297
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Report Date
    February 24, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DID NOT IDENTIFY AND NON-CONFORMITIES. THE BTT BALLOON WAS INFLATED WITH 25CC OF AIR THROUGH THE BALOON INFLATION PORT AND SUBMERGED IN WATER; THERE WERE BUBBLES OBSERVED OUT OF THE SUTURE LINE PART OF THE SILICON. THE BTT WAS INSPECTED UNDER A MICROSCOPE; THE SILICONE BALLOON WAS CRACKED (RUPTURE) IN THE SUTURE LINE SECTION. WHILE WE ARE UNABLE TO CONCLUSIVELY DETERMINE A ROOT CAUSE, EACH BTT UNDERGOES THROUGH A FULL INFLATION AND DEFLATION INSPECTION PRIOR DISTRIBUTION. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BALLOON ON THE VASO VIEW HEMOPRO WAS INFLATED FOR 5 SECONDS AND THEN POPPED. SMOKE WAS OBSTRUCTING VISUALIZATION. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169300 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25086218

    Patients

    Seq Age Sex Outcome Treatment
    1 NI